Recurrent Uti
Conditions
Brief summary
Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)
Detailed description
The overall goal of this project is to assess the feasibility of a larger trial investigating the use of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).
Interventions
DRUGGentamicin
administered via bladder
DRUGNitrofurantoin
administered PO
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal * 2 UTIs in 6 months * desire to start antibiotic prophylaxis to prevent UTIs
Exclusion criteria
* Parkinsons disease * myasthenia gravis * renal failure * liver failure * bladder pain syndrome * multiple negative urine cultures associated with UTI symptoms (\>/= 3) * bladder Botox treatments in the past * treatment planned for UI and prolapse * unevaluated microscopic hematuria * history of kidney stones * no antibiotics within 4 weeks * most recent weight \<40kg (88.18lbs) * surgically altered urinary tract (urinary diversion, phalloplasty, etc) * allergy or hypersensitivity to either of the study medications or medications in the same family including but not limited to: amikacin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess feasibility of trial recruitment | 3 months | measure screening ratio (number of people screened versus number enrolled) |
| Examine treatment compliance | 3 months | compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group |
| Examine trial retention | 3 months | compare the proportion of participants retained in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| culture-proven UTIs | 3 months | — |
| Patient reported outcome measures | 6 weeks, 3 months | UTI Symptom Assessment |
Countries
United States
Outcome results
None listed